Staying informed of the intellectual property rights of your competitors and the efforts of others to acquire a position that interferes with your product's development is a necessary part of the vaccine business. The patent landscape changes rapidly as patents issue and new patent applications are filed, but your company can stay informed of these changes. By conducting a "landscape analysis" and "patentability analysis" early in a product's research and development phases and continually monitoring publications in the field, a company can best focus the product's development, acquire the strongest patent position, and proceed to commercialization with a better understanding of the risks involved. While no search can provide a freedom to operate or patentability guarantee, knowledge of the competitive environment will provide a company with a better understanding of the road ahead.
Landscape Analysis
An initial "landscape analysis" of existing patents and published patent applications should be conducted prior to incurring significant research and development costs. Although a research plan may be founded on amazing science, if several licenses are required to bring the product to market, the product's commercial viability may be lost. Oftentimes slight formulation changes, which can easily be implemented at early stages of R&D, can avoid costly licenses. Companies should proactively design their products armed with the knowledge of others' rights in the field to avoid lost development time and costly redesigns.
Patentability Analysis
A "patentability analysis" should also be performed early in the product's life cycle and preferably before filing a utility patent application. Without patent protection, the research and development costs, not to mention the costs of obtaining regulatory approval for a vaccine, are unjustified. A patent and non-patent literature search on the technology not only may help a company avoid costly R&D on a product that has been previously described but it may also reveal potential licensing and collaboration opportunities. Additionally, an understanding of the prior art can improve your patent application's strength because one will be able to anticipate the rejections likely to be raised during examination and, in some cases, perform side-by-side experiments with previously known products to demonstrate your product's unexpected improvements.
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